Latest Review Date: November 2023

Category: Surgery                                                      

POLICY:

Injection of anesthetic for diagnosing sacroiliac joint pain may be considered medically necessary when ALL of the following criteria have been met:

• Pain has failed to respond to 3 months of conservative therapy*; AND
• Dual (controlled) diagnostic blocks** with 2 anesthetic agents with differing duration of action are used; AND
• The injections are performed under imaging guidance.

Injection of corticosteroid for the treatment of sacroiliac joint pain may be considered medically necessary when ALL of the following criteria have been met:

• Pain has failed to respond to 3 months of conservative therapy*; AND

• The injection is performed under imaging guidance; AND
• No more than 3 injections are given in one year.

Arthrography of the sacroiliac joint is considered investigational.

Radiofrequency denervation of the sacroiliac joint is considered investigational.

Cryoablation (cryodenervation, cryoneurolysis, cryosurgery, or cryoanesthesia) of the sacroiliac joint is considered investigational.

*Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in therapeutic physical medicine modality(ies) and/or manipulations when rendered by an eligible provider (including active exercise).

** A successful trial of controlled diagnostic lateral branch blocks consists of two separate positive blocks on different days with local anesthetic only (no steroids or other drugs), or a placebo-controlled series of blocks, under fluoroscopic guidance, that has resulted in a reduction in pain for the duration of the local anesthetic used (e.g., three hours longer with bupivacaine than lidocaine). There is not a consensus on whether a minimum of 50% or 75% reduction in pain would be required to be considered a successful diagnostic block, although evidence supports a criterion standard of 75% to 100% reduction in pain with dual blocks. No therapeutic intra-articular injections (i.e., steroids, saline, and other substances) should be administered for a period of at least four weeks before the diagnostic lateral branch block. The diagnostic blocks should not be conducted under intravenous sedation unless specifically indicated (e.g., the patient is unable to cooperate with the procedure).

DESCRIPTION OF PROCEDURE OR SERVICE:

Sacroiliac joint arthrography using fluoroscopic guidance with injection of an anesthetic has been explored as a diagnostic test for sacroiliac joint pain. Duplication of the patient’s pain pattern with the injection of contrast medium suggests a sacroiliac etiology, as does relief of chronic back pain with injection of local anesthetic. Treatment of sacroiliac joint pain with corticosteroids, radiofrequency ablation (RFA), and stabilization has also been explored.

Similar to other structures in the spine, it is assumed that the sacroiliac joint may be a source of low back pain. In fact, before 1928, the sacroiliac joint was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the sacroiliac joint received less research attention.

Research into sacroiliac joint pain has been thwarted by any criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, sacroiliac joint pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for sacroiliac joint pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding study of the sacroiliac joint is that multiple structures, such as posterior facet joints and lumbar discs, may refer pain to the area surrounding the sacroiliac joint.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the sacroiliac joint for the diagnosis of sacroiliac joint pain. Cryoablation is a minimally invasive procedure that involves the use of extreme cold to destroy abnormal tissue. Treatments being investigated for sacroiliac joint pain include prolotherapy (refer to policy # 235 Prolotherapy), corticosteroid injection, RFA, stabilization, and arthrodesis. For indications and coverage criteria related to sacroiliac arthrodesis and minimally invasive procedures related to the SI joint please refer to policy #555 Sacroiliac Joint Fusion. Also, this policy does not address treatment of pain in the sacroiliac joint due to infection, trauma, or neoplasm.

KEY POINTS:

The most recent literature review was performed through September 13, 2023. Following is a summary of key references to date.

Summary of Evidence

For individuals who have SIJ pain who receive therapeutic corticosteroid injections, the evidence includes RCTs and case series. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. In general, the literature on injection therapy of joints in the back is of poor quality. Results from from 1 RCTshowed superiority over a sham control group, but 2 RCTs showed that therapeutic SIJ steroid injections were not aseffective as other active treatments. Larger trials with rigorous designs and sufficient follow-up, preferably using sham injections,are needed to determine that the technology improves the net health outcome. The evidence is insufficient to determine that the technology results in animprovement in the net health outcome.

For individuals who have SIJ pain who receive RFA, the evidence includes 6 RCTs using different radiofrequency applications and case series. The relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. For RFA with a cooled probe, the 3 RCTs reported short-term benefits, but these are insufficient to determine the overall effect on health outcomes. The RCT on palisade RFA of the SIJ did not include a sham control. Another sham-controlled randomized trial showed no benefit from RFA. Further high-quality controlled trials are needed to compare this procedure in defined populations with sham control and alternative treatments. The evidence is insufficient to determine that the technology results in animprovement in the net health outcome.

Practice Guidelines and Position Statements

North American Spine Society

In 2020, NASS published coverage policy recommendation for SIJ injections and radiofrequency ablation.

1. "Diagnostic intra-articular SIJ injections. Intra-articular SIJ injections are indicated to aid in the diagnostic work-up of low back pain when ALL of the listed criteria are met. All SIJ injections should be performed with some form of radiographic image guidance (e.g., fluoroscopic, CT). The volume of injectate should be limited to 2 mL and the inclusion of steroid with local anesthetic is not inappropriate. A diagnosis of SIJ pain is confirmed with at least a 75% reduction of pain for the expected duration of the anesthetic used on 2 separate occasions.

• Patient's report of nonradicular, typically unilateral, pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain
• A physical examination typically demonstrating localized tenderness with palpation over the sacral sulcus (Fortin's point, i.e., at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) or the absence of tenderness elsewhere (eg, greater trochanter, lumbar spine, coccyx) that would explain the patient's symptoms.
• Positive response to a cluster of at least 3 provocative tests (1. Patrick's or FABER, 2. Gaenslen, 3. Thigh thrust, 4. Sacral thrust, 5. Distraction, 6. Compression). Note that the thrust tests may not be recommended in pregnant patients or those with connective tissue disorders.

2. Diagnostic anesthetic blocks of the L5 primary dorsal ramus and sacral dorsal rami lateral branches (S1-S3). Small volume (<0.5 mL per nerve) image-guided anesthetic blockade of the L5 primary dorsal ramus and 1st-3rd sacral dorsal rami lateral branches are indicated to aid in the diagnostic work-up of LBP and must be considered prior to radiofrequency lesioning of these nerves. A positive response is at least 75% reduction of pain for the expected duration of the anesthetic used on 2 separate occasions.

These block are appropriate when ALL of the listed criteria are met:

• Patient's report of nonradicular, typically unilateral, pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain
• A physical examination typically demonstrating localized tenderness with palpation over the sacral sulcus (Fortin's point, i.e., at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) or the absence of tenderness elsewhere (eg, greater trochanter, lumbar spine, coccyx) that would explain the patient's symptoms.
• Positive response to a cluster of at least 3 provocative tests (1. Patrick's or FABER, 2. Gaenslen, 3. Thigh thrust, 4. Sacral thrust, 5. Distraction, 6. Compression). Note that the thrust tests may not be recommended in pregnant patients or those with connective tissue disorders.

3. Therapeutic intra-articular SIJ injections. Image-guided intra-articular SIJ injections of corticosteroid with or without local anesthetic are indicated for the treatment of sacroiliac pain when > 1 of the listed criteria are met:

• Clinical criteria for diagnostic SIJ injection are met (as above in item 1) AND pain has been present for at least 1 month AND pain is > 4/10 with functional limitation OR any pain level with functional limitation despite other conservative treatment.
• SIJ pain has been confirmed with diagnostic intra-articular SIJ injections.
• SIJ pain has recurred following a previous therapeutic SIJ injection which resulted in >50% pain relief for > 3 months.
• Advanced imaging (bone scan or MRI) demonstrate uptake or inflammation in the SIJ.

4. Patients with spondyloarthopathies such as ankylosing spondylitis. Radiofrequency neurotomy of the L5 primary dorsal ramus and sacral dorsal rami lateral brances (S1-S3). Image-guided radiofrequency neurotomy of the L5 primary dorsal ramus and sacral dorsal rami lateral branches at S1, S2, and S3 are indicated for the treatment of sacroiliac pain when wither of the listed criteria are met:

• Clinical criteria for positive diagnostic anesthetic blocks of the L5 dorsal ramus and sacral dorsal rami lateral branches (as above in item 2) are met AND pain has been present for at least 3 months AND pain is severe enough to cause some degree of functional deficit despite other conservative treatment.
• Posterior sacroiliac ligament complex pain has recurred after > 50% improvement for > 6 months from prior radiofrequency neurotomy of the L5 primary dorsal ramus and sacral dorsal rami lateral branches."

NASS posted a protocol for a forthcoming systematic review and guideline on SIJ pain, "Diagnosis and Treatment of Adults with Sacroiliac Joint Pain: A Protocol for a Systematic Review and Clinical Guideline by the North American Spine Society" in February, 2023. The review aims to provide evidence-based recommendations to address critical clinical questions surrounding diagnosing and treating adult patients with sacroiliac joint pain. No estimated date of publication was provided.

American Society of Interventional Pain Physicians Interventional Pain Management

American Society of Interventional Pain Physicians Interventional Pain Management guidelines were updated in 2013. The updated guidelines recommend the use of controlled sacroiliac joint blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of sacroiliac joint pain. A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic sacroiliac joint injections.

American Society of Anesthesiologists et al

In 2010, the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine Practice updated their guidelines for chronic pain management. The guidelines recommend that diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected sacroiliac joint pain. Based on opinions of consultants and society members, the guidelines recommend that water-cooled RFA or sacroiliac joint injections may be used for chronic sacroiliac joint pain.

American Pain Society

The 2009 practice guidelines from the American Pain Society (APS) were based on a systematic review that was commissioned by the APS and conducted at the Oregon Evidence-based Practice Center. The APS guideline states that there is insufficient evidence to evaluate validity or utility of diagnostic sacroiliac joint block as a diagnostic procedure for low back pain with or without radiculopathy and that there is insufficient evidence to adequately evaluate benefits of sacroiliac joint steroid injection for non-radicular low back pain.

American Society of Pain and Neuroscience

In 2021, the American Society of Pain and Neuroscience published practice a guideline on radiofrequency neurotomy. All of the workgroup members utilized radiofrequency neurotomy in clinical practice. A consensus statement, based on Grade II-1 evidence(well-designed, controlled, nonrandomized clinical trial), was that "lateral branch radiofrequency neurotomy may be used for the treatment of posterior sacral ligament and joint pain following positive response to appropriately placed diagnostic blocks."

In 2022, ASPN published guidance on the treatment of lower back pain. The following recommendations were provided concerning SIJ injections, minimally invasive sacroiliac joint fixation and sacroliliac radiofrequency ablation:

• Sacroiliac joint injections have been associated with positive predictive value in the diagnosis of SIJ dysfunction (Grade, A; Level, I-A; Level of certainty, Strong)
• Sacroiliac joint injections demonstrate short term relief of SIJ dysfunction (Grade, B; Level, I-B; Level of certainty, Moderate)
• Minimally invasive sacroiliac fusion (Grade, A; Level, 1-A; Level of certainty, High)
• SI joint denervation/ablation is effective in treatment of SI joint dysfunction pain and is superior to sham in RCT (Grade, A; Level, I-A; Level of certainty, High)

U.S. Preventive Services Task Force Recommendations

Not Applicable.

KEY WORDS:

Arthrography, Sacroiliac Joint Arthrography, Sacroiliac Joint Radiofrequency Ablation or Denervation, SI joint Injections, Diagnostic Blocks, Cryodenervation, Cryoneurolysis, Cryosurgery, Cryoanesthesia, Cryoablation

APPROVED BY GOVERNING BODIES:

A number of radiofrequency generators and probes have been cleared for marketing through the U.S. Food and Drug Administration’s (FDA) 510(k) process. One device, the SInergy® by Halyard; formerly Kimberly Clark/Baylis, is a water-cooled single-use probe that received FDA clearance in 2005, listing the Baylis Pain Management Probe as a predicate device. The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

HCPCS

REFERENCES:

1. Benzon HT, Connis RT, De Leon-Casasola OA, et al. Practice guidelines for chronic pain management: an updated report bythe American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of RegionalAnesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4): 810-33.
2. Chappell ME, Lakshman R, Trotter P, et al. Radiofrequency denervation for chronic back pain: a systematic review and metaanalysis. BMJ Open. Jul 21 2020; 10(7): e035540.
3. Chen CH, Weng PW, Wu LC et al. Radiofrequency neurotomy in chronic lumbar and sacroiliac joint pain: A meta-analysis. Medicine (Baltimore), 2019 Jul 3;98(26).
4. Chou R, Atlas SJ, Stanos SP et al. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976) 2009; 34(10):1078-1093.
5. Chou R, Fu R, Dana T, Pappas M, Hart E, Mauer KM. Interventional Treatments for Acute and Chronic Pain: Systematic Review.Comparative Effectiveness Review No. 247. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No.75Q80120D00006.) AHRQ Publication No. 21-EHC030. Rockville, MD: Agency for Healthcare Research and Quality; September 2021.
6. Chou R, Loeser JD, Owens DK et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976) 2009; 34(10):1066-1077.
7. Cohen SP, Kapural L, Kohan L, et al. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study. Reg Anesth Pain Med. Jul 05 2023.
8. Dreyfuss P, Michaelsen M, Pauza K et al. The value of medical history and physical examination in diagnosing sacroiliac joint pain. Spine (Phila Pa 1976) 1996; 21(22):2594-2602.
9. Hansen H, Manchikanti L, Simopoulos TT et al. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician 2012; 15(3):E247-278.
10. Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA. Jul 04 2017; 318(1): 68-81.
11. Kennedy DJ, Engel A, Kreiner DS, et al. Fluoroscopically guided diagnostic and therapeutic intra-articular sacroiliac joint injections: A systematic review. Pain Med. Aug 2015; 16(8):1500-1518.
12. Kim WM, Lee HG, Jeong CW et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med 2010; 16(12):1285-1290.
13. Lee DW, Pritzlaff S, Jung MJ, et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): Best PracticeGuidelines from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2021; 14: 2807-2831.
14. Manchikanti L, Abdi S, Atluri S et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician 2013; 16(2 Suppl):S49-283.
15. Manchikanti L, Datta S, Derby R et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 1. Diagnostic interventions. Pain Physician 2010; 13(3):E141-174.
16. Manchikanti L, Datta S, Gupta S et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician 2010; 13(4):E215-264.
17. Mehta V, Poply K, Husband M et al. The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial. Pain Physician, 2018 Dec 5;21(6). 
18. North American Spine Society (NASS). NASS coverage policy recommendations. https://www.spine.org/coverage.
19. Patel N. Twelve-month follow-up of a randomized trial assessing cooled radiofrequency denervation as a treatment for sacroiliac region pain. Pain Pract. Feb 2016; 16(2):154-167.
20. Patel N, Gross A, Brown L et al. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med 2012; 13(3):383-389.
21. Rupert MP, Lee M, Manchikanti L et al. Evaluation of sacroiliac joint interventions: a systematic appraisal of the literature. Pain Physician 2009; 12(2):399-418.
22. Simopoulos TT, Manchikanti L, Gupta S et al. Systematic Review of the Diagnostic Accuracy and Therapeutic Effectiveness of Sacroiliac Joint Interventions. Pain Physician, 2015 Oct 3;18(5).
23. van Tilburg CW, Schuurmans FA, Stronks DL, et al. Randomized sham-controlled double-blind multicenter clinical trial to ascertain the effect of percutaneous radiofrequency treatment of sacroiliac joint pain: three-month results. Clin J Pain. Nov 2016; 32(11):921-926.
24. Visser LH, Woudenberg NP, de Bont J et al. Treatment of the sacroiliac joint in patients with leg pain: a randomized-controlled trial. Eur Spine J 2013; 22(10):2310-2317.
25. Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: A open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014; 34(9):1195-1202.

POLICY HISTORY:

Medical Policy Panel, May 2014

Medical Policy Group, July 2014 (3): New Policy removed section from policy 303 related to SI joint injections as well as section from 141 related to SI joint denervation

Medical Policy Administration Committee, August 2014

Available for comment September 8 through October 22, 2014

Medical Policy Group, September 2014 (3): added word “modality(ies)” to description of physical therapy in conservative therapy definition per Medical Director

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (2): 2015 Updates to Description, Key Points, Current Coding- added CPT code 20552, and References; no change to Policy statement.

Medical Policy Group, May 2015 (2): HCPCS codes G0259 and G0260 added to policy.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (2): Updates to Key Points, Approved by Governing Bodies, and References; no change in policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (7): Updates to Key Points and References. Policy Statement intent remains unchanged. Clarification to wording – removed “for the purpose” and added “anesthetic for.”

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (7): Updates to Key Points. No change in Policy Statement.

Medical Policy Group, March 2017 (7): Updates to Description, Key Points, Key Words, Current Coding- added CPT code 64999, and References. Also, added cryoablation as investigational to Policy Statement.

Available for comment March 30 through May 13, 2017

Medical Policy Group, April 2017 (7): Clarification to “conservative therapy” definition.

Medical Policy Panel, December 2017

Medical Policy Group, December 2017 (7): 2017 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (7): 2019 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Added CPT codes 64451 and 64625 to the Current coding section. No change in Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (7): Updates to Key Points and References. Removed the previous policy statement prior to May 2017. No change in Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (7): Updates to Key Points and References. Removed “not medically necessary” statement from Policy Statement. No change in intent.

Medical Policy Panel, November 2022

Medical Policy Group, January 2023 (7): Minor updates to Key Points. No change in Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (7): Updates to Key Points and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1.  The technology must have final approval from the appropriate government regulatory bodies;
2.  The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3.  The technology must improve the net health outcome;
4.  The technology must be as beneficial as any established alternatives;
5.  The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1.  In accordance with generally accepted standards of medical practice; and
2.  Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3.  Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.